EMA Grants Exclusive Marketing Authorization for the Orphan Drug TEPADINA® to ADIENNE Pharma & Biotech
News Mar 23, 2010
ADIENNE Pharma & Biotech and RIEMSER Arzneimittel AG announce that the European Medicines Agency (EMA) has granted the exclusive marketing authorization to ADIENNE Pharma & Biotech for the orphan medicinal product TEPADINA® for conditioning treatment prior to haematopoietic progenitor cell transplantation. RIEMSER Arzneimittel AG is the exclusive worldwide manufacturer. The companies agreed to commercialize the product in close cooperation in their respective territories.
TEPADINA® obtained Orphan Drug Designations by the EMA for the indication "Conditioning treatment prior to haematopoietic progenitor cell transplantation" and by US Food and Drug Administration (FDA) for the indication "Conditioning treatment prior to haematopoietic stem cell transplantation" in 2007.
TEPADINA® can be used to treat haematological diseases such as leukaemia, lymphoma, multiple myeloma and thalassemia and also specific solid tumors where allogenic or autologous haematopoietic progenitor cell transplantation is a treatment option.
"ADIENNE Pharma and Biotech mission has always been the research and development of orphan drugs for the treatment of severe diseases with particular attention to the field of transplant. Thanks to the exclusive marketing authorization granted to our Orphan Drug TEPADINA®, we are fulfilling our company mission. I am also very pleased with the support received by RIEMSER Arzneimittel AG for TEPADINA® production and I'm also confident in future cooperation between the two companies", Dr. Antonio Francesco Di Naro, Founder and CEO of ADIENNE Pharma and Biotech, says.
"I am very grateful to ADIENNE Pharma & Biotech whose tremendous and highly professional efforts resulted in the granted license for TEPADINA®. The international, innovative cooperation between our two companies now allows us to offer critically ill patients who are dependent on such treatment an effective therapeutic option", Dr. Michael Mehler, CEO of RIEMSER Arzneimittel AG, notes.
TEPADINA® will be available in Italy and Spain through ADIENNE Pharma & Biotech and in Germany through RIEMSER Arzneimittel AG. Further countries will follow successively, wherein close cooperation in marketing and regional distribution in the European Union is agreed upon.
The companies will now enter into discussions with the respective local authorities to commercialize TEPADINA®.
"With the launch of TEPADINA® we at RIEMSER will consistently continue our strategic orientation as a specialty pharma company. We are strengthening our key therapeutic area of oncology and haematology and further expanding our international presence", Dr. Michael Mehler, CEO of RIEMSER Arzneimittel AG, emphasizes.